A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma (NCT00924989) | Clinical Trial Compass
CompletedPhase 3
A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma
United States139 participantsStarted 2009-12-01
Plain-language summary
A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent OSI-906 in patients with locally advanced/metastatic Adrenocortical Carcinoma (ACC) who received at least 1 but no more than 2 prior drug regimens
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed adrenocortical carcinoma that is locally advanced or metastatic and not amenable to surgical resection.
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1).
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<= 2
* Predicted life expectancy \>= 12 weeks.
* At least 1 but no more than 2 prior drug regimens (including molecular targeted therapy, systemic cytotoxic chemotherapy, biologics, and/or vaccines) for locally advanced/metastatic ACC.
* A minimum of 3 weeks must have elapsed between the end of prior treatment and randomization.
* All patients must have received prior mitotane, either as neoadjuvant, adjuvant, or locally advanced/metastatic therapy.
* Adjuvant and neoadjuvant mitotane therapy will not be counted as prior drug regimens or as systemic cytotoxic chemotherapy.
* Prior radiation therapy is permitted provided patients have recovered from the acute, toxic effects of radiotherapy prior to randomization.
* A minimum of 21 days must have elapsed between the end of radiotherapy and randomization.
* Prior surgery is permitted provided that adequate wound healing has occurred prior to randomization.
* Fasting glucose \< = 150 mg/dL (8.3 mmol/L).
* Adequate hematopoietic, hepatic, and renal function defined as follows: Neutrophil count \>= 1.5 x 10\^9 /L;
* Platelet count \>= 100 x 10\^9 /L;
* Bilirubin \<= 1.5 x Upper Limit of Normal (ULN);
* AST and ALTā¦
What they're measuring
1
Overall survival of single agent OSI-906 versus placebo